510(k) DEN140022
DEN140022 is an FDA 510(k) premarket notification submitted by Innovatex, Inc. for the device "GLAUCOMA COMPANION". The FDA issued a decision of De Novo Granted on April 20, 2016. The device falls under product code PLX (Tear Duct Occluder), a Class I device regulated under 21 CFR 886.5838.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 20, 2016
- Date Received
- July 18, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tear Duct Occluder
- Device Class
- Class I
- Regulation Number
- 886.5838
- Review Panel
- OP
- Submission Type
A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the duct.